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Light Therapy for Chronic Insomnia in General Practice (Insolux)

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ClinicalTrials.gov Identifier: NCT04612192
Recruitment Status : Not yet recruiting
First Posted : November 2, 2020
Last Update Posted : November 2, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Study Description
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Brief Summary:
  • Sleep disorders, especially insomnia
  • Attention deficits (or disorders), daytime somnolence and drug dependence
  • The goal is to evaluate whether light therapy could be used as an efficient alternative treatment with direct application in general practice

Condition or disease Intervention/treatment Phase
Insomnia Chronic Sleep Disorder Circadian Rhythm Disorders Device: Active luminette Device: Placebo luminette Not Applicable

Detailed Description:

Insomnia affects 15 to 20% of the general French adult population and increases with age. General practitioners (GPs) are the first confronted to sleep disorders, especially insomnia.

Cognitive-behavioral therapies (CBT) have proven effective, but their implementation in everyday practice is limited, and alternative treatments are still needed.

Light not only has a great influence on the sleep-wake cycle and alertness, but also on mood and cognitive functions.

The administration time of light condition will be calculated for each individual in a modality that has no impact on the circadian phase.

Study will be conduct on an outpatient basis in general practice

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Light Therapy for Chronic Insomnia in General Practice: a Randomized Double Blind Study
Estimated Study Start Date : February 2021
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024
Arms and Interventions
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Arm Intervention/treatment
Experimental: Active light
active blue-enriched bright light
 Device: Active luminette
receive an active blue-enriched light-glasses of 1500 lux (an average of 180 photons/s/cm2, with a maximum wavelenght at 468 nm), 30-minute long light therapy in the morning, in a time period defined by sleep log and chronotype questionnaire, on a 4-week period
Placebo Comparator: Placebo light
dim red placebo light
 Device: Placebo luminette
receive a dim red-light placebo light (an average of n photons/s/cm2, single- band spectrum with a narrow peak at 660 nm under 50 lux), with the same modality as the experimental group


Outcome Measures
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Primary Outcome Measures :
  1. Difference of sleep efficiency between active and placebo light condition [ Time Frame: Before light therapy ]
    ratio of total sleep time on total time in bed in measured with actimetry

  2. Difference of sleep efficiency between active and placebo light condition [ Time Frame: After 4 weeks of light therapy ]
    ratio of total sleep time on total time in bed measured with actimetry


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   randomisation by sex
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Complaining of chronic insomnia according to ICSD-3 (International Classification of Sleep Disorders) criteria and/or taking hypnotics at least 3 nights per week for more than 3 months.
  • Non-hypnotic medication: stable medication during one month preceding the inclusion and for the 8 weeks of the study.
  • Compliance with the treatment: the patient is able to have light therapy during the required time and at the agreed schedule.

Exclusion Criteria:

  • Severe psychiatric disorder (severe major depression, schizophrenia, bipolar disorder), obvious acute psychiatric comorbidity.
  • Untreated intrinsic sleep pathology: sleep apnea syndrome based on clinical criteria: Berlin questionnaire score, restless legs syndrome manifesting more than 2 times a week and/or requiring treatment.
  • Mild to severe dementia.
  • Neurodegenerative sleep troubles
  • Severe intercurrent pathology.
  • Ophthalmic troubles presenting a contraindication to light therapy: retinopathy, age-related macular degeneration, diabetic retinopathy, macular hole, epiretinal membrane); lens opacifications (cataract) justifying surgery (correction of poor visual acuity, visual discomfort); glaucomatous and non-glaucomatous optic neuropathy resulting in visual impairement.
  • Toxicomania, chronic alcoholism.
  • Secondary insomnia linked to somatic non-stabilized pathology.
  • Elements influencing circadian rhythm
  • Pregnancy, breastfeeding.
  • Participation in another interventional clinical trial which includes an exclusion period
  • No information could be given to the patient (subject faces emergency situation, comprehension difficulties, etc.)
  • Patient under guardianship
  • Non hypnotic treatment potentially inducing a level 3 sleepiness one week before
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04612192


Contacts
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Contact: Juliette CHAMBE, MD (0)3 88 79 08 02 ext +33 juliette.chambe@unistra.fr
Contact: Fabien ROUGERIE, MD (0)3 88 80 00 73 ext +33 frougerie@unistra.fr

Locations
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France
University of Nantes
Nantes, France, 44210
Contact: Cédric RAT, MD       Cedric.Rat@univ-nantes.fr   
CHU Reims
Reims, France, 51092
Contact: Aline HURTAUD, MD       aline.hurtaud@wanadoo.fr   
Hôpitaux Universitaires de Strasbourg
Strasbourg, France, 67091
Contact: Juliette CHAMBE, MD       Juliette.chambe@unistra.fr   
Contact: Eve RENAUD         
Sponsors and Collaborators
University Hospital, Strasbourg, France
More Information
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT04612192    
Other Study ID Numbers: 7348
First Posted: November 2, 2020    Key Record Dates
Last Update Posted: November 2, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Initiation and Maintenance Disorders
Sleep Wake Disorders
Chronobiology Disorders
Disease
Pathologic Processes
 Sleep Disorders, Intrinsic
Dyssomnias
Nervous System Diseases
Mental Disorders
Neurologic Manifestations